Thirteen female subjects were present during the focus group meetings, of whom 9 suffered from OAB and 4 from mixed urinary incontinence (MUI) (Table 1). Saturation of input, the point during the study where no new input was brought in, was reached after two meetings.
The majority of patients experienced urgency as an intensified sensation of the normal urge. One patient experienced no urgency but only pain in the lower abdomen prior to urinary leakage. Another patient experienced leakage without prodromal sensations. Urgency to defecate was also incorporated in ‘Uromate’, since some patients stated that both urinary and faecal urgency occurred simultaneously.
Patients noted that liquid intake, the amount rather than the nature of the liquid, was a very important item. Most patients adjusted the amount of fluid intake when going outside. Coffee or tea were not mentioned as voiding triggers.
Several somatic complaints were included in the proposed list of questions for ‘Uromate’, such as palpitations, sweating, shortness of breath, dizziness, muscle pain and painful joints. A few patients experienced the whole range of proposed somatic complaints. However, focus group participants could not mention one specific non-urological somatic complaint associated with OAB. Additionally, patients advised to add vaginal pain as a somatic symptom to the list of questions.
Furthermore, patients were asked to point out the least relevant psychological items, leading to a substantially shortened list of items. ‘Energetic’, ‘enthusiastic’, ‘happy’, ‘strong’, ‘worried’, ‘inspired’, ‘disappointed’, ‘insecure’ and ‘guilty’ were removed, because patients found those items not to be associated with OAB.
Situation and company, were very important factors, influencing the psyche and severity of complaints. Patients stated that they felt uncomfortable in situations where people did not show understanding of their urological complaints. They felt that people do not take their complaints seriously.
A morning questionnaire was developed to evaluate the symptom pattern during the night. Participants considered the frequency of awakening and whether awakening was due to urological symptoms the most important.
Initially, sexuality questions were not incorporated, because repeated assessment was not considered useful. Nevertheless, patients missed questions about sexuality in the list of ‘Uromate’ items. To them, sexuality was an important item, because their sexual functioning was impaired due to OAB complaints. Hence, integration in the morning questionnaire was proposed.
The next step in the development of ‘Uromate’ was the expert meeting. During this meeting the list of questions was shortened by making sub-questions in the case of positive answers. A validated icon of the Visual Prostate Symptom Score (VPSS) depicting the urinary stream was added. The experts decided to use a validated 4-points urgency scale. Additionally, it was decided to evaluate the degree of untenability as well, using a 11-points NRS. Moreover, there was agreement between experts and focus group participants on merging muscle- and joint complaints together, in order to identify a possible link between OAB and fibromyalgia. Experts decided to add scrotal pain and prolapse sensation as gender-specific questions. Most of the initial psychological items, considering positive affect, were removed during the focus group interviews. However, experts agreed that a couple of positive options must be present in the ESM-questionnaire, whereas otherwise a negative response bias might be introduced. Therefore, the items ‘cheerful’ and ‘relaxed’ were kept as positive affect items to maintain an overall neutral question tone. The items ‘anxious’, ‘lonely’ and ‘nervous’ were removed to prevent response fatigue. Carbonated drinks were not incorporated in the questions, because there is little evidence on the association with urinary complaints. Morning questions about sexuality were added, such as pain and urinary urgency and incontinence during intercourse.